Customized Patient Instruments for Total Knee Replacement

The TruMatch Solutions program from DePuy Orthopaedics brings a new level of personalized Total Knee Replacement

surgery to your OR, allowing you to work with femoral and tibial cutting guides individually prepared to match the

alignment criteria and actual bone surfaces of each patient. The design software takes into account your own surgical

preferences. With TruMatch Solutions, you are able to provide a knee treatment designed around the individual needs of

your patients.

Delivering customized patient instrumentationthrough advanced technology.

TruMatch™ Personalized Solutions is based on the

proven philosophy of mechanical alignment.

Instruments that match the natural anatomy of your patient.

Individually shaped to fit securely to the bone.

Predetermined key surgical cuts - based on the patient's mechanical alignment.

Our rigorous approach to technological innovation means you can have confidence

in offering a knee treatment that is right for you, and your patient.

EfficiencyReduced surgical steps

Fewer standard instruments needed

Fewer instrument cases to resterilize

Facilitates faster OR turnover

FunctionElimination of up to nine steps from the surgical workflow

Eliminates the need, and assembly, of the femoral IM rod guide,

sizing guide and the tibial resection guide

Based on the patient’s mechanical alignment

Wear Resistance

3D plan of the whole leg structure

Facilitates proper implant placement and alignment, a key factor in

reducing polyethylene wear in total knee replacement

Determination of distal femoral and proximal tibial resection levels,

varus/valgus alignment, femoral rotation and tibial slope

Upon your approval, DePuy will manufacture the customized instruments based upon the listed information supplied by you. DePuyn to

the customized instruments to be manufactured or supplied pursuant to your request and therefore makes no warranty and disclaims an

warrants that the customized instruments to be supplied under this request are merchantable, of good quality and free from defects,whether patent or latent, in materials or workmanship; and that the customized instruments sold hereunder conform to or exceed thehigher grading standards recognized by DePuy's industry. DePuy further warrants that it has good title to the customized instrumentsand that the customized instruments are free and clear from all liens and encumbrances.

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06/14/2010

Ref. Case # CPIK003SM

OrderType TKA

Dr. TCEtester2

Please review the following patient proposal. On your DePuy TruMatch website use the "Make Decision" button to

select the appropriate status for this case. Once your approval and feedback has been submitted, manufacturing

of the custom guides will begin.

Please contact DePuy TruMatch Support if you have any questions or need further information.

Toll Free number: 1-800-689-0746

E-mail: TruMatchSupport@dpyus.jnj.com

Cordially,

DePuy Orthopaedics - TruMatch Design Team

Proposal Revision: 2

Alignment: (NOTE: All TruMatch resections are planned with varus/valgus angle perpendicular to the mechanical axis)

Fem. Sizing Ref.: Anterior Down External Rotation Ref: Posterior Condyles External Rot.: 0

Distal Fem. Resect: 5.0 + 1.0 = 6.0 Distal Resection Ref: Mechanical Axis Valgus Rot.: 0

Prox. Tib. Resect: 5.0 + 0.0 = 5.0 Posterior Tib. Slope: 0

Surgeon Name: Dr. Shr TCEtester2 Facility: St. Mary 's

Contact Email: shr.tcetester2@tcua.com

Device Information:

Implant System: PFC Sigma Instrument System: HP

Fem. Component: Sz 6 PS L Poly Component: Sz 6 Tib Component: Fixed Bearing

Patient Name: B Smith

Gender: M DOB: 1945-01-12 Height: 5 ft, 10 in Weight: 220 lb L

Patient Special Considerations:

Varus Cartilage Loss: M: 100% L: 75% Surgery Date: 2011-01-07

Notes/Comments:

warranty that such customized instruments are �t and su�cient for the purpose intended. Notwithstanding the foregoing, DePuy For example only

Your patient's 3D anatomy data and your personal surgical preferences

are used together to define the Patient Proposal.

DePuy Orthopaedics takes this information and then creates a

Patient Proposal based on mechanical alignment.

The TruMatch Solutions website allows you to review, approve, change,

re-design or cancel any Patient Proposal at any stage of the process.

Software that delivers your plan.

With a three-dimensional plan of the whole leg structure, the TruMatch Solutions team of engineers

will model resection guides to provide mechanical alignment through the new total knee. These

will determine distal femoral and proximal tibial resection levels, varus/valgus alignment, femoral

rotation and tibial slope.

Wear Resistance, a key factor in an implant’s long-term success is, in addition to implant design,

strongly driven by correct implant alignment. Proper alignment is enabled by a combination of

surgical skill and precise instrumentation.

Patient Imaging

Following an assessment and

recommendation from the

surgeon, the TruMatch Solutions

process begins with a CT scan

of the whole leg, from hip to

ankle, per a defined TruMatch

Solutions scanning protocol. The

CT scan will be conducted at a

certified imaging center (local

to the surgeon) and will then be

electronically forwarded to our

TruMatch Solutions team. The

team will confirm the quality of

the scan and create a new patient

record for later submission by the

surgeon’s office.

Case Submission

Through a simple web interface,

the surgeon’s office finalizes

the pertinent case information

and submits the order to the

TruMatch Solutions design team.

Immediately, the system will

provide the delivery date of the

finalized blocks. Surgery can be

scheduled any time thereafter,

up to six months. The case

information will be collated

with the surgeon’s surgical

preferences already recorded in

the system. Together with the

implant geometry, the TruMatch

Solutions design team will prepare

a customized patient proposal.

Image Processing and

Patient Proposal

Utilizing proprietary software,

the TruMatch Solutions design

team will create a complete

three dimensional model of the

whole leg structure, which will

be combined with the patient’s

information and the surgeon’s

surgical preferences to create

a customized patient proposal.

The patient proposal will include

information such as distal femoral

and proximal tibial resection

levels, varus/valgus alignment,

femoral rotation and tibial slope.

The seamless TruMatch Solutions process

Patient Proposal Approval

An e-mail will alert the surgeon

when the case specific patient

proposal is ready for his/her

comment and approval. The

surgeon is then able to visit a

password protected area of the

TruMatch Solutions website to

make, if necessary, any revisions

and approve the proposal.

Instrument Preparation

and Kit Consolidation

Once the surgeon approves

the details of the proposal,

preparation of the customized

patient instruments takes

place within our dedicated

manufacturing center. Individual

patient name and data are etched

on each, to confirm identification

in the OR. Stainless steel guides

within the RenShape™ plastic

blocks are designed to minimize

particle generation during cutting.

Delivery and Surgery

The TruMatch Solutions resection

guides are delivered sterile.

The guides are delivered on,

or prior to, the stated delivery

date communicated during

the case submission step.

Surgery can take place any time

thereafter up to six months.

Printed in USA. ©2010 DePuy Orthopaedics, Inc. All rights reserved.

2.5M07100612-17-510

For more information on DePuy knees, please visit our website at www.depuyknees.com